Be Careful What You Ask For

Yes it seems the folks in Northridge aren’t all that happy these days. Suggestions have been made that we have been overly harsh on the company. Some have suggested that we should examine the MAUDE database to see what’s going on with Tandem, Dexcom and the FreeStyle Libre. Fair enough so we did just that and here’s what we found;

Tandem

Pretty much normal insulin pump adverse events. What we didn’t find and believe us we looked was any problems that indicated there was a problem with the Dexcom sensor which communicates with the company’s Basal IQ system. What we didn’t find is any strange issues related to reservoirs. What we didn’t find is an excessive amount of reports given the company’s installed user base.

As we said pretty much normal stuff for an insulin pump. Nothing that would indicate there could be structural issue with the pump, the sensor which works with the pump or the insulin dosing algorithm.

Dexcom

The biggest issue with the G6 isn’t the sensor itself but the app that works with the sensor. By far the biggest issue reported was loss of connectivity which based on reading the reports is more of an app issue than a sensor issue.

What we didn’t find was a boatload of reports about the sensor being inaccurate and we looked for it.

FreeStyle Libre

While there were some reports related to accuracy issues but none which surprised us given what is publicly known about how the Libre performs. It’s well know that Libre has an issue in the low range and issue by the way which is addressed in the label for the system. It is also know given the publicly available data that the Libre is not quite as accurate as the G6 but the two systems are getting closer in terms of performance.

Now why any of this matters to Medtronic is quite frankly beyond us as what’s happening at other companies does not hide the fact to what’s going on at Medtronic. Whether the company chooses to acknowledge it or not the fact is they have a major problem with their sensor. A sensor which is critical to the 670G. A sensor which when inaccurate can and based on the reports is creating major problems for patients.

Nor does this address the issue of the reservoir which we now believe is an attempt to cover up a bigger problem. As we noted yesterday there were just too many reports which noted that a patient experienced higher than normal glucose readings. Nothing unusual with any insulin pump but very unusual as the reservoir has nothing to do with glucose levels. All the reservoir does is hold insulin. Now if reservoirs were leaking or cracked yes this could cause higher than normal levels. And yes there were some reports which noted this. However there were far to many reports that noted glucose levels outside of range.

Listen all medical devices have issues this as they say comes with the territory. Medical devices are not infallible they can and do fail or malfunction. Nothing new here. However as we noted yesterday when any link in the 670G chain fails it can have lethal consequences. The fact is any closed loop system, not just the 670G, should be held to highest standard possible. The pump, the sensor and the insulin dosing algorithm working together should be held to the strictest standards.

Frankly we are not surprised by Medtronic reaction. They have a problem on their hands, they aren’t sure what to do about it so let’s do the old Texas two step and try to divert attention by looking at what their competitors are doing. Only problem here is when you look at what the competition is doing it only reinforces that it’s not the competition that has a problem but Medtronic who has a problem.

Since we have published these pieces the flood gates have opened. Email after email from patients on the 670G or physicians who have prescribed it indicate what we said before; a love hate relationship. When it works it’s great, when it doesn’t it sucks. The same is true when looking at all the social media platforms and patient blogs. Something Medtronic says they are doing but obviously not with much vigor.

See Medtronic knows they hold all the keys to the kingdom. They have the largest installed user base and they own the most valuable piece of real estate. They know the competition cannot match their scale nor do they have the financial resources to compete effectively. They know it is not a level playing field and want to keep it that way. They also know they don’t have to have the best system just one that keeps the goose laying those golden eggs.

The last thing they want is for the FDA to start taking a closer look at these reports. For the FDA just might discover what we have, something is rotten in Northridge. Do we believe the FDA made a mistake approving the 670G NO WE DO NOT. Do we think these reports demand further investigation ABSOLUTELY. This isn’t and never has been about any one company or system this is all about patient safety.

Medtronic can continue to stick their head in the sand. They can continue to try and divert attention from what looks to be a serious problem. Yet as Momma Kliff used to say, there is a strange thing about the truth for it really does set you free. The fact is the truth as ugly as it may be and as much as people like to avoid it always wins.

Are we expecting Medtronic to be perfect, NO. When you are in the medical device business this just isn’t possible. Are we expecting Medtronic to publicly admit the issues, NOPE. But we do expect them to FIX THE PROBLEM AND NOT TO AVOID IT JUST BECAUSE IT MIGHT HURT THEIR BOTTOM LINE.

We’ll say it again because it’s true what made MiniMed great back in the day was rule number one was to put the patient first, rule number two was to reread rule number one. Based on what we are seeing with Medtronic rule one is to avoid any responsibility whatsoever and rule number two is let’s protect that golden goose at all costs, even if that means patients get the shaft.